DTM (TM) Spinal Cord Stimulation (SCS) Study

Launched by MEDTRONICNEURO · Oct 19, 2020

Keywords

ClinConnect Summary

This post market study will measure the following:

* Visual Analog Scale
* Programming Parameters

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older
• • Willing and able to provide signed and dated informed consent
• • Capable of comprehending and consenting in English
• • Candidate per labeling for an SCS system as an aid in the management of chronic, intractable pain of the trunk and/or limbs
• • Has moderate to severe back and leg pain
• • Stable pain medications for back and leg pain for at least 28 days prior to enrollment
• • Willing and able to comply with all study procedures and visits
• • Willing and able to not increase their pain medications through the 3-Month visit
• • Able to differentiate between pain associated with the indication for SCS implant and other types of pain
• Exclusion Criteria:
• • Previously trialed or implanted with a stimulator or intrathecal drug delivery system
• • Expected to be inaccessible for follow-up
• • Current diagnosis of moderate to severe central lumbar spinal stenosis with symptomatic neurogenic claudication
• • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
• • If female, is pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
• • Has untreated major psychiatric comorbidity
• • Serious drug-related behavioral issues
• • Unable to achieve supine or prone position
• • Classified as vulnerable or requires a legally authorized representative (LAR)